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From the 7/23/2021 release of VAERS data:

Found 11,940 cases where Vaccine is COVID19 and Patient Died



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1490255 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-21
Onset:2021-07-21
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027A21A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016B21A / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypothyroidism, diabetes mellitus, depressive disorder, schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Family reported patient had increased seizures after receiving vaccines. No documented hx of seizures prior to vaccines.


VAERS ID: 1490511 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-07-01
Onset:2021-07-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose increased, Cardiac arrest, Condition aggravated, Diabetes mellitus, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin
Current Illness: None known
Preexisting Conditions: CHF, NIDDM
Allergies: NKDA
Diagnostic Lab Data: BGL 600
CDC Split Type:

Write-up: Family notes patient started to have issues controlling blood glucose levels, prior to day of event patient had syncope episodes. 7/21/2021 patient had sudden cardiac arrest.


VAERS ID: 1490551 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-20
Onset:2021-07-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Work       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trulicity, Aspirin, Metoprolol, Lipitor, Metformin
Current Illness: N/A
Preexisting Conditions: NIDDM, HTN, Obesity, CAD, Hyperlipidemia, Hx of MI, Heart Failure
Allergies: NKDA
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: UNKNOWN COVID-19 vaccine was administered within the community on the same day patient expired. Family might have this information. Was not shared with us.


VAERS ID: 1496478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-20
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C14-02 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210743981

Write-up: HEART ATTACK; This spontaneous report received from a health care professional concerned a 7 decade old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 21C14-02 expiry: 31-MAR-2023) dose was not reported,1 total administered on 19-JUL-2021 11:00 a.m. at left deltoid for prophylactic vaccination. No concomitant medications were reported. Reporter stated that thirty two hours after vaccination patient died of heart attack at 21:45 p.m. on 20-JUL-2021. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210743981-Covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK


VAERS ID: 1490902 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-15
Onset:2021-07-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Blood glucose normal, Cardiac arrest, Cardioversion, Chest tube insertion, Cyanosis, Death, Electrocardiogram abnormal, Endotracheal intubation complication, Mini-tracheostomy, Muscle tightness, Pulse absent, Pupil fixed, Resuscitation, Reversal of opiate activity, Unresponsive to stimuli, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: diphenhydrAMINE/lidocaine/aluminum hydroxide/magnesium hydroxide/simethicone mucous membrane suspen , HX SIG - FOR REFERENCE ONLY: SWISH AND SPIT 5 ML BY MOUTH EVERY TWO HOURS AS NEEDED FOR SORE THROAT, MOUTH IRRITATION OR PAIN, Mouth or th
Current Illness: Sarcoidosis with recurrent syncope and possible tachyarrhythmia, concern for possible cardiac vs CNS sarcoid (7/9/21) Bipolar disorder Chronic pain/opioid use
Preexisting Conditions: Opioid overdose and hospitalization (5/27/21) Asthma Autoimmune sensorineural hearing loss Bipolar disorder Constipation Elevated creatine kinase level Fibromyalgia Long term methotrexate user Low back pain Morbid obesity Neuropathy History of Non-Hodgkin lymphoma PTSD - Post-traumatic stress disorder Sarcoidosis Syncope Tachycardia
Allergies: morphine (Anaphylaxis) immune globulin intravenous (Rash)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pfizer COVID vaccine dose #2 administered 15 Jul 2021 @ 07:59. ED physician documentation on 19 Jul 2021: "37-year-old female came the emergency department after found down by her husband. Has a history of attempted overdose in the past,, she was found down by her husband at 545, and unresponsive on scene. Medic was on scene and patient was noted to be in V. fib and therefore CPR was started, compressions were in progress upon arrival, however the patient remained in cardiac arrest. Other history was able to be gathered from the patient or family, however EMS stated that they had found that her glucose was 99 on scene, and she been given full dose Narcan as well on scene. And was shocked 3 times a 200 J, she was given 2 doses of epinephrine, as well as 300 of amiodarone. They attempted to intubate the patient however the patient was clamped down, and therefore they could not pass any sort of apparatus to control the airway, therefore they placed a nasal trumpet. Pertinent physical exam findings: Jaw clamped shut, pupils fixed, and was obviously cyanotic, no palpable pulses. No chest rise. EKG as interpreted by me (ED attending): Monitor showed that the patient was in asystole the entire time. Medical Decision making and plan of care: Patient was immediately moved from gurney onto bed, and chest compressions were continued without interruption. Given that the patient was in V. fib in the field, we did decide to place dual pads for dual sequential defibrillation, is on the plats however, the patient was noted to be in asystole, therefore chest compressions were continued, epinephrine, as well as calcium, as well as bicarb. See code chart for further details. IO was also placed in the patient''s left proximal tibia. Regarding the patient''s airway, several attempts were made to pass an ET tube, as well as paralyzed the patient with rocuronium, however tube passing was unsuccessful, and therefore I performed a cricothyrotomy. Followed by bilateral finger thoracostomies. See procedure notes below for further details. Despite 5 rounds of ACLS, with multiple doses of epinephrine, as well as bicarb and calcium carbonate administered, the patient remained in cardiac arrest, death was declared at 1851."


VAERS ID: 1484118 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin
Current Illness: Nil
Preexisting Conditions: Nil
Allergies: Nil
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 1491016 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-02-16
Onset:2021-07-18
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9266 / 2 - / -

Administered by: Senior Living       Purchased by: ?
Symptoms: Death, Femur fracture
SMQs:, Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: not known. Was not a resident at Beecher manor at time of vaccination.
Current Illness: not known. Was not a resident at Beecher manor at time of vaccination.
Preexisting Conditions: Diverticulitis, Anxiety, Dysphagia, Dementia, GERD, Osteoarthritis, Neuropathy, Osteoporosis, Cognitive Communication deficit
Allergies: no known allergies
Diagnostic Lab Data: none completed during end of life hospice comfort care.
CDC Split Type:

Write-up: Admitted 4/1/2021 and discharged to Sunrise assisted living 5/14/21. Return admission to Hospital from hospital 7/17/21 w/dx R femur fracture under Hospice Comfort Care for end of life. Expired at facility 7/18/21 at hospital.


VAERS ID: 1484665 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-04-09
Onset:2021-07-17
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Chills, Death, Diarrhoea, Dyspnoea, Intensive care, Productive cough, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: COVID 19 Death - 7/17/2021 - Admitted to ICU from ED with symptoms of shortness of breath, productive cough, diarrhea, and chills. Started 1 week ago. COVID19 PCR positive while in ED. Diagnosed with COVID19 Pneumonia. Expired later on same day 7/17/2021.
CDC Split Type:

Write-up: COVID 19 Death - 7/17/2021 - Admitted to ICU from ED with symptoms of shortness of breath, productive cough, diarrhea, and chills. Started 1 week ago. COVID19 PCR positive while in ED. Diagnosed with COVID19 Pneumonia. Expired later on same day 7/17/2021.


VAERS ID: 1484918 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-27
Onset:2021-07-17
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9269 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9810 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Death, Seizure like phenomena
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death R56.9 - Seizure-like activity (CMS/HCC) Cardiac arrest


VAERS ID: 1485039 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-06-28
Onset:2021-07-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac death, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: High Pressure; Neuropathy; Diabetes
Preexisting Conditions: Diabetes; High Pressure
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died of a heart attack on 07/17/2020 while sleeping.


VAERS ID: 1485234 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 2 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN LISPRO, DIGOXIN,PAROXETINE MESYLATE, PRO-STAT, VYNDAMAX, MIRTAZAPINE, POTASSIUM, MULTIVITAMINS, LOPERAMIDE HCL, ADVAIR DISKUS, BUMETANIDE, ATORVASTATIN, APIXABAN, PANTOPRAZOLE SODIUM, LOSARTAN POTASSIUM
Current Illness:
Preexisting Conditions: CHF, DIABETES MELLITUS TYPE 2, UNSPECIFIED ASTHMA, ABNORMAL POSTURE, ATRIAL FLUTTER, HYPOOSMOLALITY, HYPONATREMIA, ABNORMAL LEVELS OF ENZYMES, GERD, DEPRSSIVE DISORDER, FLUID OVERLOAD, HYPERTENSIVE AND HEART DISEASE, HYPERLIPIDEMIA, ANEMIA, ATRIAL FIBRILLATION
Allergies: SULFA, ERYTHROMYCIN
Diagnostic Lab Data:
CDC Split Type:

Write-up: DEATH THE FOLLOWING DAY


VAERS ID: 1481360 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-09
Onset:2021-07-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT DEATH


VAERS ID: 1490927 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-21
Onset:2021-07-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, Cardio-respiratory arrest, Death, Endotracheal intubation, Intensive care, SARS-CoV-2 test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aspergillus lung infection, MAC prophylaxis
Preexisting Conditions: Non Hodgkin''s lymphoma, asplenia, marginal zone lymphoma, autoimmune hepatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to hospital with acute hypoxemic resp failure. Pt had history of COVID19 infection in Nov 2020. Pt has chronic medical conditional including but not limited to marginal zone lymphoma on chemo, h/o aspergillus, MAC on atovoqone and voriconazole. Pt received moderna vaccine in May (1st shot), and June (2nd shot). Pt admitted on 7/16 found to have positive covid infection second time. Pt resp status steadily worsen from NC to reservoir, and then HFNC. Despite on remdesivir, prednisone, antibiotics, and antifungal. Pt had code blue due to resp arrest, intubated, then coded again in ICU for over 1 hour. Family elevated make patient DNR, and she died soon after on 7/20.


VAERS ID: 1478618 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-06-25
Onset:2021-07-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Resuscitation, Seizure like phenomena, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: homebound client for vaccine outreach, this RN not precisely sure of circumstances leading up to "homebound" status.
Allergies: none reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported deceased to public health today. Date of death: 7/15/2021. Sister of patient reports that case reported chest pain while at home walking on his treadmill, he then had to lie down and sister asked him if he was having pain and wanted ambulance called. Reports that patient declined 911 call. Sister then reports that patient had what looked like a seizure, but then went completely unresponsive, so she initiated CPR and called 911. Reports that CPR and 911 response was not successful and patient passed away.


VAERS ID: 1487416 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-04
Onset:2021-07-15
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN9581 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: No
Allergies: Azo Urinary Tract Defense, Clindamycin, Codeine, Doxycycline, Peniccillians, Sulfas.
Diagnostic Lab Data: Patient COVID-19 positive by PCR on 07/04/2021.
CDC Split Type:

Write-up: The patient expired 7/15/2021 under Hospice care.


VAERS ID: 1490980 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-02-05
Onset:2021-07-15
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / 2 - / -

Administered by: Senior Living       Purchased by: ?
Symptoms: Death, General physical health deterioration, Laboratory test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: apap, acidophilis, amytriptyline, amlodipine, ativan, atorvastatin, famotidine, Eliquis, Depakote, morphine, metoprolol, losarten, duo neb, Keppra
Current Illness: no acute
Preexisting Conditions: Collapsed vertebrae, CVA, anxiety, Dysphagia, Altered mental status, Atelectasis, Aphasia, Afib, HTN, Osteoarthritis, diverticulitis, Breast implant, Gastrostomy
Allergies: Sotalol, Adhesive Tape
Diagnostic Lab Data: Under hospice care, limited labs and not aggressive treatment. Focus on comfort.
CDC Split Type:

Write-up: Steady decline under hospice care which began 1/4/2021 r/t CVA hx. Mild improvment at times with consistent decline throughout until expiration 7/15/21 at facility.


VAERS ID: 1491031 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-02-05
Onset:2021-07-15
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN9581 / 2 - / -

Administered by: Senior Living       Purchased by: ?
Symptoms: Death, Facial paralysis, Gastrostomy, Hemiparesis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: apap, acidophilus, ativan, plavix, lasix, potassium chloride
Current Illness: Conjunctivitis
Preexisting Conditions: Dementia, CHF/HTN, Osteoporosis,
Allergies: no known drug allergies. Laundry soap, Scented products
Diagnostic Lab Data: none during end of life hospice care.
CDC Split Type:

Write-up: Stable at time of vaccine 1/15/21 and 2/5/21, Transferred to ER for pocketing food, Left facial drooping and left sided weakness on 7/4/21. Returned from hospital 7/14/21 w/gastrostomy nutritional status and hospice care. She expired w/end of life hospice care in place on 7/15/21.


VAERS ID: 1478056 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-02-19
Onset:2021-07-14
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025L20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M2OA / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Apnoea, COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cyanosis, Death, Dyspnoea, Fatigue, Fibrin D dimer, Hypoxia, Lung opacity, Oedema, Pain, Pneumonia, SARS-CoV-2 test positive, Sputum increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown med list at time of vaccinations. Medication list at time of admission include - Coreg, vitamin B12 injections, Aricept, Synthroid, prazosin, Crestor, Zyprexa, albuterol, ferrous sulfate, mag oxide, omeprazole, sertraline
Current Illness:
Preexisting Conditions: Hypertension, hyperlipidemia, hypothyroidism, peptic ulcer disease, sick sinus syndrome
Allergies:
Diagnostic Lab Data: 7/14: SARS-CoV-2 PCR + 7/14 D-dimer 1.93 7/14: CXR Bilateral patcy airspace opacities consistent with multifocal pneumonia vs edema 7/14: Chest CT probable right LL and right ML pneumonia
CDC Split Type:

Write-up: Presented to ED with shortness of breath. Tested + for COVID-19 at nursing home 1 day prior to presentation. Reports complaints of increasing fatigue, body aches, and respiratory difficulties. Was hypoxic on arrival to ER and required high flow nasal cannula at 45L 60% FiO2 initially. Admitted to floor for oxygen/dexamethasone treatment. Patient''s oxygen was titrated as needed. The day following admission patient developed apnea/cyanosis with large amounts of thick sputum. Patients respiratory status declined rapidly and patient expired.


VAERS ID: 1485423 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dyspnoea, Pyrexia, Respiratory distress, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Mycophenolate mofetil, rituximab (last administered 4/2021), losartan, furosemide, metoclopramide, cyclobenzaprine, gabapentin, calcium carbonate
Current Illness: He had an ED visit for headaches (which resolved after administration of migraine cocktail), with normal head imaging.
Preexisting Conditions: Mixed connective tissue disease complicated by ILD (which was stable on most recent imaging and PFTs), pulmonary hypertension (with normal RVSP on recent echocardiogram), Raynaud''s , and sensory $g$g motor polyneuropathy.
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: After his office visit with me on Tuesday 7/13, the patient went to get the Moderna COVID vaccine. He received the vaccine on Tuesday evening. On Wednesday, he developed new fevers as high as 104F (measured at home). Fevers improved with Tylenol. He did not report his symptoms, as per his wife, he assumed this was related to the COVID vaccine. By the following morning, his fevers had resolved. He took a nap midday, and shortly after waking, he reported to his wife that he was feeling short of breath. According to his wife, he appeared in respiratory distress and she heard wheezing. He asked to be helped to the ground, and she immediately called EMS. Unfortunately, before they could get him to a hospital, he died. At the hospital, his wife was told that because his death was outside the hospital, it was presumed to be due to "natural causes". She was told an autopsy would cost $5000, which she could not afford.


VAERS ID: 1475434 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-07-07
Onset:2021-07-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: enlarged heart
Allergies: unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient died 6 days after receiving dose #2


VAERS ID: 1484107 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: arrhythmia, presumed MI, death


VAERS ID: 1487285 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-02-23
Onset:2021-07-12
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6202 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cymbalta, Imdur, Klor-Con, Lasix, Prinivil, Norvasc, magnesium oxide, Flaxseed oil, calcium/vitamin D, cerovite senior tab, plavix, toprol, pepcid, tylenol, aspirin
Current Illness:
Preexisting Conditions:
Allergies: Zocor, Crestor
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away on 07/12/2021


VAERS ID: 1494091 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-24
Onset:2021-07-12
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9269 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chills, Diarrhoea, Dizziness, Dyspnoea, Fatigue, Nausea, Pyrexia, SARS-CoV-2 test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: Diabetes Mellitus, chronic kidney disease, and cardiovascular disease
Allergies: unknown
Diagnostic Lab Data: Patient tested positive for COVID 7-12-21
CDC Split Type:

Write-up: Patient was admitted to medical facility on 7-12-21. She had fever, chills, nausea/vomiting, fatigue, shortness of breath, diarrhea, and light headed


VAERS ID: 1484325 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-12
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse reaction, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20210732004

Write-up: SHORTNESS OF BREATH; ADVERSE REACTION TO THE VACCINE; This spontaneous report received from a consumer via a company representative concerned a 36 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 12-JUL-2021 14:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-JUL-2021 (four hours after vaccination) at 18:00, the patient was hospitalized with shortness of breath, and some other unspecified symptoms and died on the same day due to unspecified adverse reaction to the vaccine. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of adverse reaction to the vaccine and shortness of breath on 12-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210732004-covid-19 vaccine ad26.cov2.s- Shortness of breath, adverse reaction to the vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ADVERSE REACTION TO THE VACCINE


VAERS ID: 1485770 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003190 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL
Current Illness: Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.5 degree celsius
CDC Split Type: JPTAKEDA2021TJP058475

Write-up: Subarachnoid hemorrhage; This spontaneous case was reported by a physician and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003190) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)). Concomitant products included CANDESARTAN CILEXETIL for Hypertension. On 08-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) (seriousness criteria death and medically significant). The patient died on 13-Jul-2021. The reported cause of death was Subarachnoid haemorrhage. An autopsy was performed. The autopsy-determined cause of death was Subarachnoid haemorrhage. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.5 (Low) 36.5 degree celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) to be possibly related. concomitant product included atorvastatin calcium hydrate. No treatment information was given. Very limited information regarding this event has been provided at this time. No further follow-up information is expected The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected; Reported Cause(s) of Death: Subarachnoid haemorrhage; Autopsy-determined Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1489121 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021873410

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional received via the Agency and from the Regulatory Authority. Regulatory authority report number is v21119927. The patient was a non-pregnant 91-year-old female received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date: 30Sep2021) via intramuscular route of administration on 10Jul2021 at 13:45 (the day of vaccination)(at the age of 91-Year-old, Non-pregnant), in left arm as dose 1, single for COVID-19 immunisation. The patient had no other medical history or disease under treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products (allergies were not described in the vaccination coupons). Concomitant medications were not reported. The reported event was as follows: The medical history and others were not reported. Since the vaccination, the patient has not been tested for COVID-19: Unknown. On 10Jul2021 (the day of vaccination), the patient was followed up for 15 minutes after the vaccination. On 12Jul2021 (two day of vaccination), after the patient went home, she was emergently transferred, and she died at the hospital where she was transferred to. On 12Jul2021 (two day after the vaccination), the patient experienced death. The event resulted in death. The cause of death was unknown. It was unknown whether autopsy was performed or not. The outcome of the event was fatal with unknown treatment. The reporting other healthcare professional assessed the event as serious (death). The causality between the event and BNT162b2 vaccination was not provided.; Reported Cause(s) of Death: Death


VAERS ID: 1493329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-12
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood pressure diastolic, Blood pressure systolic, Body mass index, Death, Dyspnoea, Echocardiogram
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOLACTONE; ATORVASTATIN; KVENTIAX; PERINDOPRIL ARGININE/INDAPAMIDE/AMLODIPINE; METFORMIN
Current Illness: Coronary heart disease; Heart failure NYHA class II; Insomnia; Obesity (1. stage BMI 34.02 on 2021/07/08); Primary hypertension (start year around 2011, well controlled with medication); Type II diabetes mellitus (Start year 2019 last blood test in 2020 diabetes well controlled with diet and medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20181206; Test Name: Echocardiogram; Result Unstructured Data: Dyskinesia in left ventricle septal wall; Test Date: 20190108; Test Name: Coronary angiogram; Result Unstructured Data: No stenoses found; Test Date: 20210708; Test Name: Blood pressure systolic; Result Unstructured Data: 120 mmHg; Test Date: 20210708; Test Name: Blood pressure diastolic; Result Unstructured Data: 70 mmHg; Test Date: 20210708; Test Name: Body mass index; Result Unstructured Data: BMI = 34.02
CDC Split Type: LVJNJFOC20210741803

Write-up: DEATH; LABOURED BREATHING; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, LV-SAM-2021076266] concerned a 67 year old female. The patient''s weight was 86 kilograms, and height was not reported. The patient''s concurrent conditions included primary hypertension, heart failure HA (Heart Association) class II, coronary heart disease, type 2 diabetes mellitus, obesity, and insomnia. On 06-DEC-2018, Laboratory data included: echocardiogram showed dyskinesia in left ventricle septal wall. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-01) 0.5 ml, 1 total, administered on 08-JUL-2021 for prophylactic vaccination in left deltoid as 1st immunization dose. Concomitant medications included atorvastatin for coronary heart disease, quetiapine fumarate for insomnia, amlodipine besilate/indapamide/perindopril arginine for primary hypertension, spironolactone for primary hypertension, and metformin for type 2 diabetes mellitus. On 08-JAN-2019, laboratory data included Coronary angiogram which showed no stenoses found. On 08-JUL-2021, laboratory data included blood pressure diastolic which showed 70 mm[Hg], blood pressure systolic which showed 120 mm[Hg], and Body mass index showed BMI equals to 34.02. On 12-JUL-2021, the patient had laboured breathing. On the same date, the patient died. The cause of death was unknown. It was unknown whether the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of laboured breathing on 12-JUL-2021. This report was serious (Death).; Sender''s Comments: V0-20210741803- covid-19 vaccine ad26.cov2.s -Death and laboured breathing . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: DEATH


VAERS ID: 1464398 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-26
Onset:2021-07-09
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3EN5318 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Death
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death Acute renal failure (ARF)


VAERS ID: 1470235 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-02-25
Onset:2021-07-09
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011A21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Catastrophic reaction, Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Medication List As of 7/8/2021 10:18 AM Diclofenac Sodium 0.1 % No dose, route, or frequency recorded. Furosemide 40 mg Oral DAILY Patient taking differently: Take 20 mg by mouth daily Lisinopril 5 mg Oral DAILY metFORMIN HCl 500 mg
Current Illness:
Preexisting Conditions: Problem List As of 7/8/2021 9:39 AM Chronic atrial fibrillation Hypovitaminosis D Type 2 diabetes mellitus without complication, without long-term current use of insulin Essential hypertension Chronic systolic heart failure Chronic kidney disease, stage III (moderate) Acquired hypothyroidism Mixed hyperlipidemia Neuropathy Anemia Elevated LFTs Acute thrombus of left ventricle NSVT (nonsustained ventricular tachycardia) Hypomagnesemia Hypokalemia PVD (peripheral vascular disease) Azotemia Chronic anticoagulation Fissure in skin of both feet Ulcer of heel and midfoot, left, limited to breakdown of skin Ulcer of heel and midfoot, limited to breakdown of skin, right Onychomycosis Pain in toes of both feet Ischemic cardiomyopathy Cataract of left eye Cataract extraction status of eye, right
Allergies: no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: catastrophic stroke on 7/9/21, death on 7/10/21


VAERS ID: 1474425 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: RESP. DISTRESS AND DEATH


VAERS ID: 1486071 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cough, Diarrhoea, Dyspnoea, Oropharyngeal pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: General complaints of feeling unwell, no specific symptoms
Preexisting Conditions: DM 2
Allergies: None
Diagnostic Lab Data: none
CDC Split Type:

Write-up: daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat


VAERS ID: 1487270 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-02-17
Onset:2021-07-09
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol, dulcolax, senna, tylenol, roxanol, haldol, ativan, atropine sulfate, diphenhist, benadryl
Current Illness:
Preexisting Conditions:
Allergies: Brazil nuts
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away on 07/09/2021


VAERS ID: 1487432 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-02-19
Onset:2021-07-09
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EL3302 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Protonix, Synthroid, Lasix, Toprol, Tylenol, Aranesp, Colace, Calazime, Dialyvite, vanicream, Viscosup
Current Illness:
Preexisting Conditions:
Allergies: Cholecalciferol
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away on 07/09/2021


VAERS ID: 1479956 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Chest X-ray, Idiopathic pulmonary fibrosis, Interstitial lung disease, Mouth breathing, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SOLANAX; PIRESPA; CARBOCISTEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Home care; Hyposthenia; Idiopathic interstitial pneumonia; Idiopathic pulmonary fibrosis; Respiratory disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: decreased; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210709; Test Name: Chest X-ray photography (Xp); Result Unstructured Data: Test Result:revealed a spread of bilateral diffuse ground glas; Comments: revealed a spread of bilateral diffuse ground glass opacity
CDC Split Type: JPPFIZER INC2021872344

Write-up: Acute aggravation of interstitial pneumonia; Acute aggravation of idiopathic pulmonary (IP); Maintaining SpO2 was not possible with oxygen administration at a maximum dose.; the blood pressure decreased simultaneously with respiratory and cardiac arrest; jaw breathing; the blood pressure decreased simultaneously with respiratory and cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21119158. The patient was a 70-year and 12-month-old male. On 02Jul2021, the patient''s body temperature before vaccination was 36.5 degrees centigrade. Family history reported as follows: The patient had a subjective symptom of respiratory discomfort since around 2019. With a diagnosis of idiopathic interstitial pneumonia (idiopathic pulmonary fibrosis [IPF]) at 2 other hospitals, the patient began to have difficulty visiting hospitals, and since Dec2020, the reporting clinic had been providing home-visit medical care. The patient was on home care for idiopathic pulmonary fibrosis and was in a state of hyposthenia. Concomitant medications included alprazolam (SOLANAX tablet 0.4 MG) oral at 0.4 mg as needed (for the time of sleeplessness), pirfenidone (PIRESPA tablet 200 MG) oral at 600 mg thrice daily (morning, noon, and evening), and carbocisteine (manufactured by JG, tablet 500 MG) oral 500 mg thrice daily (morning, noon, evening). On an unknown date, the patient previously received the first dose of BNT162b2 (Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 02Jul2021 at 10:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration at the age of 70-year-old as the second single dose for COVID-19 immunisation. On 09Jul2021 at 7:30 (6 days after the vaccination), the patient experienced acute aggravation of interstitial pneumonia. At emergency house visit, jaw breathing was already noted. On 09Jul2021, Chest X-ray photography (Xp) was performed and revealed a spread of bilateral diffuse ground glass opacity. Acute aggravation of idiopathic pulmonary (IP) was considered. Maintaining SpO2 was not possible with oxygen administration at a maximum dose. It had been planned since before that the patient would be observed under home care. Even intubation was performed, recovery was unlikely, and observation under the present condition was decided with the consent of the family. Although steroids and fluid infusion were started, the blood pressure decreased simultaneously with respiratory and cardiac arrest, and death was confirmed on 09Jul2021. It was not reported whether autopsy was done. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was acute aggravation of idiopathic pulmonary fibrosis.; Reported Cause(s) of Death: Acute aggravation of interstitial pneumonia


VAERS ID: 1459979 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D21A / 1 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flomax Capsule 0.4 MG (Tamsulosin HCl) Vitamin D3 Tablet (Cholecalciferol) Aspirin Tablet Delayed Release 81 MG LaMICtal Tablet 100 MG (lamoTRIgine) Losartan Potassium Tablet 50 MG Ativan Tablet 0.5 MG (LORazepam) PROzac Capsule 40 MG
Current Illness: No acute illnesses at time of vaccination
Preexisting Conditions: PARKINSON''S DISEASE POSTHERPETIC GENICULATE GANGLIONITIS BIPOLAR DISORDER, UNSPECIFIED TRANSIENT CEREBRAL ISCHEMIC ATTACK, UNSPECIFIED ANXIETY DISORDER, UNSPECIFIED MAJOR DEPRESSIVE DISORDER, RECURRENT, SEVERE WITH PSYCHOTIC SYMPTOMS UNSPECIFIED MOOD [AFFECTIVE] DISORDER ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS INSOMNIA, UNSPECIFIED OTHER ABNORMALITIES OF GAIT AND MOBILITY UNSPECIFIED OSTEOARTHRITIS, UNSPECIFIED SITE SENSORINEURAL HEARING LOSS, BILATERAL COGNITIVE COMMUNICATION DEFICIT DYSPHAGIA, OROPHARYNGEAL PHASE AGE-RELATED PHYSICAL DEBILITY RETENTION OF URINE, UNSPECIFIED DIZZINESS AND GIDDINESS BENIGN PROSTATIC HYPERPLASIA WITH LOWER URINARY TRACT SYMPTOMS SOLITARY PULMONARY NODULE
Allergies: Sinemet
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Resident was given Moderna COVID vaccine dose #1 on 7/7/2021 around 10:40 am and was found deceased on 7/8/2021 at 4:10 pm. Member had no acute illnesses/adverse reactions identified prior to death.


VAERS ID: 1464197 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-02-12
Onset:2021-07-08
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions: Chronic kidney disease, HTN, DM
Allergies: No
Diagnostic Lab Data: Positive COVID test
CDC Split Type:

Write-up: Patient Expired


VAERS ID: 1484959 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-24
Onset:2021-07-08
   Days after vaccination:106
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cerebrovascular accident, Death, Facial paresis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death Acute CVA (cerebrovascular accident) Facial weakness


VAERS ID: 1490965 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-05-10
Onset:2021-07-08
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Senior Living       Purchased by: ?
Symptoms: Aspiration, Clostridium difficile colitis, Cough, Death, Dyspnoea, Laboratory test, Lethargy, Pneumonia, Pneumonia aspiration, Pneumonitis, Sepsis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Pseudomembranous colitis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not aware of meds at time of vaccination. Admitted to Beecher Manor 6/28/2021.
Current Illness: Not aware of illnesses at time of vaccination. Admitted to Beecher Manor 6/28/2021.
Preexisting Conditions: COPD, CHF, Chronic Kidney Disease.
Allergies: Cipro, Medrol
Diagnostic Lab Data: Testing and labs completed at hospital.
CDC Split Type:

Write-up: Resident was vaccinated. Pt was admitted on 6/28 with dx of pneumonia, cdiff and sepsis. On admission pt noted to have dry cough and lethargy. Pt had signs of aspiration and dyspnea and was sent to ED for evaluation within five hours of admission to Beecher Manor. She was treated for aspiration pneumonia w/diagnosis of pneumonitis r/t food and vomit. She was re-admitted to Beecher Manor on 7/3 with orders for Augmentin PO 7/4 - 7/9. She continued to decline w/plans by family to begin Hospice care. She expired during process of initiating hospice care.


VAERS ID: 1477527 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Pneumonia aspiration, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 36.7; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 37.8; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 38; Test Date: 20210708; Test Name: percutaneous oxygen saturation (SpO2); Result Unstructured Data: 87 percent
CDC Split Type: JPTAKEDA2021TJP057666

Write-up: Sepsis; Aspiration pneumonia; This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis) and PNEUMONIA ASPIRATION (Aspiration pneumonia) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002337) for COVID-19 vaccination. Family history included Dementia Alzheimer''s type. Concurrent medical conditions included Dementia Alzheimer''s type. On 07-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria death and medically significant) and PNEUMONIA ASPIRATION (Aspiration pneumonia) (seriousness criteria death and medically significant). The patient was treated with ACETAMINOPHEN on 08-Jul-2021 for Pyrexia, at a dose of 100 mg. The patient died on 08-Jul-2021. The reported cause of death was Sepsis and aspiration pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 37.8 (High) 37.8 and 38 (High) 38. On 08-Jul-2021, Oxygen saturation: 87 (abnormal) 87 percent. On an unknown date, Body temperature: 36.7 (Inconclusive) 36.7. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SEPSIS (Sepsis) and PNEUMONIA ASPIRATION (Aspiration pneumonia) to be possibly related. The patient''s body temperature before vaccination was 36.7 degree Celsius. On 08-Jul-2021, at 06:00 AM the patient had sputum sticking sensation. On 08-Jul-2021, at 07:00, the signs of circulatory failure were noted. At 08:25, the patient experienced pyrexia of 38.0 degrees Celsius and took antipyretic (acetaminophen 100 mg) through a gastric fistula. At 09:45, the sign of respiratory failure was noted with percutaneous oxygen saturation (SpO2) of 87 percent. At 11:25, the patient had cardiopulmonary arrest. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear. This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sepsis; Aspiration pneumonia


VAERS ID: 1489112 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Cardiac failure chronic; Disuse syndrome; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:160/80; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:no fever
CDC Split Type: JPPFIZER INC2021863517

Write-up: Acute on chronic heart failure; This is a spontaneous report from a contactable pharmacist received via Pfizer sales representative. The patient was an 89-year-old male. Medical history included cardiac failure chronic and hypertension. Concomitant medications were not provided. Before the patient was transferred to the reporter''s hospital, the patient was diagnosed with disuse syndrome, but he was admitted to the reporter''s hospital under diagnosis of cardiac failure chronic and hypertension. The patient was bedridden, therefore a gastrostomy tube could not be placed. He was not receiving the treatment for hypertension. His most recent blood pressure level was around 160/80, around thisb level indicated PHg. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) at 0.3 mL via an unspecified route of administration as a single dose for COVID-19 immunization (at the age of 89-year-old). Before the second dose of vaccination, his consciousness level decreased, but he had no fever on that day, so he received the vaccination. On 08Jul2021 (1 day after the vaccination), the patient''s condition changed and died. A death certificate said that he died of acute on chronic heart failure. It was not reported if an autopsy was performed. The reporting pharmacist classified the event as serious (fatal outcome). The physician in charge stated that the patient died of old age and the causal relationship with BNT162b2 was uncertain. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the limited information in the case a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Acute on Chronic Heart Failure. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Acute on chronic heart failure


VAERS ID: 1496684 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021862773

Write-up: CPA; Dissecting aortic aneurysm; This is an initial spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 74-years-old female patient received bnt162b2 (COMIRNATY), single dose via an unspecified route of administration on 08Jul2021 10:00 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunization at doctor''s office (age at vaccination of 74 years old). The patient''s medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported whether the patient received any other medications within 2 weeks of vaccination. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Historical vaccine included on 17Jun2021 at 09:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW0201, Expiration date 30Sep2021) via an unspecified route of administration for COVID-19 immunization. The patient experienced Cardiopulmonary arrest (CPA) and dissecting aortic aneurysm, both on 08Jul2021 13:00 (3 hours after the vaccination). The patient died on 08Jul2021. The events resulted in emergency room visit and death. No treatment was provided for the events. Autopsy was not performed. The reporting physician classified the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the limited information in the case report, a possible causal relationship between event Cardio-respiratory arrest, Aortic dissection and suspect product BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: CPA; Dissecting aortic aneurysm


VAERS ID: 1496704 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood test, Body temperature, Glycosylated haemoglobin, Low density lipoprotein
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Blood (cardiac blood); Result Unstructured Data: Test Result:troponin T positive; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210626; Test Name: HbA1c; Test Result: 8.0 %; Test Date: 20210626; Test Name: LDL cholesterol; Result Unstructured Data: Test Result:137
CDC Split Type: JPPFIZER INC2021864163

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable other health professional received from the Regulatory Agency (RA). Regulatory authority report number is v21118591. This is also received from a contactable pharmacist received via other Regulatory Agency. A 76 year 7 months years old male patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) intramuscular on 03Jul2021 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included diabetes mellitus. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, Lot# FA7338, Expiration date 30Sep2021), via an unspecified route of administration on 12Jun2021 as dose 1, single for COVID-19 immunisation. On 03Jul2021 (the day of vaccination), the patient received the second single dose of BNT162b2. On 08Jul2021 estimated at 03:00 (5 days after the vaccination), the patient died by acute myocardial infarction. The course of the event was as follows: On 26Jun2021, HbA1C was 8.0% and LDL cholesterol was 137. On 07Jul2021 at 21:30, the patient was last confirmed alive. On 08Jul2021 at 06:00, the patient was found to fell in a toilet, for which ambulance was requested. However, since postmortem rigidity was observed, the patient was not transferred. On the same day, autopsy was conducted at the reporting hospital. Blood (cardiac blood) showed troponin T positive and it was assessed as acute myocardial infarction. Death date and time was 08Jul2021 at 03:00 (estimation). Since the vaccination, it was unknown whether the patient has been tested for COVID-19. The outcome of the event was fatal without treatment. The reporting pharmacist classified the event as serious (death). The reporting other health professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting other health professional commented as follows: Causality could not be denied. ; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1460255 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-06-30
Onset:2021-07-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood alkaline phosphatase increased, Condition aggravated, Death, Dyspnoea, Glycosylated haemoglobin, Haemoglobin normal, Loss of consciousness, Metabolic function test normal, Nausea, Oedema peripheral, Platelet count normal, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline ProAir inhaler Oxycodone/acetaminophen Omeprazole Hydroxyzine Gabapentin
Current Illness: Lower extremity edema, increasing shortness of breath prior to vaccination
Preexisting Conditions: COPD fibromyalgia deconditioning tobacco use
Allergies: Azithromycin Bee allergy (anaphylaxis) Zolpidem
Diagnostic Lab Data: Labs obtained 7/6/21 with elevated WBC 16,000. Hgb 16.0. Platelets normal. Complete metabolic panel normal aside from elevated alkaline phosphatase of 205. Hemoglobin A1c 6.5.
CDC Split Type:

Write-up: Patient received COVID vaccine on 6/30/21. She had been experiencing chronic dyspnea, lower extremity edema. On 7/7 had some nausea, vomiting at home. Found unconscious by her spouse a few hours later and subsequently died.


VAERS ID: 1486808 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-17
Onset:2021-07-07
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9261 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Death
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death N17.9 - Acute renal failure, unspecified acute renal failure


VAERS ID: 1490520 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-20
Onset:2021-07-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Death, Dyspnoea, Fatigue, Microbiology test normal
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented with fatigue and SOB starting about a week after vaccination. Was admitted to hospital SOB. No evidence of TTS. Progressive ARDS and death in 2 weeks after admission. Microbiology negative. No aetiology identified.


VAERS ID: 1492543 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose abnormal, Blood glucose increased, Blood test, Cardioversion, Dyspnoea, Heart rate, Investigation, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: blood sugar; Result Unstructured Data: Test Result:286; Comments: At 03:52; Test Name: blood examination; Result Unstructured Data: Test Result:Unknown results; Test Name: cardioversion; Result Unstructured Data: Test Result:Unknown results; Comments: direct current cardioversion (DC) was performed 3 times; Test Name: heart rate; Result Unstructured Data: Test Result:Unknown results; Comments: The heart rate did not recover; Test Name: pulse; Result Unstructured Data: Test Result:unknown results; Comments: pulse was not palpable; Test Name: lab examination; Result Unstructured Data: Test Result:unknown results; Comments: common carotid artery and the radial artery were palpable
CDC Split Type: JPPFIZER INC2021865659

Write-up: The blood sugar level was 286; Loss of consciousness; stertorous breathing; vomiting; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. Regulatory authority report number is v21118508. A 51-year and 8-month-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, on 06Jul2021 at 11:00 (at the age of 51 years), as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The family history was not provided. Body temperature before vaccination was not provided. The points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was not reported. On 07Jul2021 at 03:30 (16 hours and 30 minutes after the vaccination), the patient experienced loss of consciousness. The course of the event was reported as, on 06Jul2021 (the day of vaccination), at 11:00, the patient received the first dose of BNT162B2 vaccination. The patient had a normal life without a large change until going to bed. At 22:00 (11 hours after vaccination), the patient was confirmed to have a normal life. At 03:30 (16 hours and 30 minutes after vaccination), the patient had loss of consciousness in the left lateral decubitus position in the futon (Japanese bedding), and no response was obtained. Thus, an ambulance was called. At 03:42 (16 hours and 42 minutes after vaccination), an ambulance service arrived. There were marks of vomiting. The patient had stertorous breathing. The consciousness level was 3 digits. The common carotid artery and the radial artery were palpable. The airway was secured manually. At 03:52 (16 hours and 52 minutes after vaccination), the patient was put into the ambulance. The blood sugar level was 286. At 03:53 (16 hours and 53 minutes after vaccination), the stertorous breathing disappeared. The pulse was not palpable. A cardiac massage was initiated. At 04:32 (17 hours and 32 minutes after vaccination), the patient arrived in the hospital. The intravenous route was secured. A blood examination was performed. Adrenalin was intravenously administered (the total of 7A), and direct current cardioversion (DC) was performed 3 times. The heart rate did not recover. At 05:10 (18 hours and 10 minutes after vaccination), the patient was confirmed to die. The dead body was transferred by the police (the subsequent situation was unknown). It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of all events. The patient underwent lab tests and procedures which included blood glucose abnormal: 286. The outcome of the event vomiting was unknown and rest of the events were fatal. The reporting other healthcare professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was not reported about other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Loss of consciousness; stertorous breathing; The blood sugar level was 286


VAERS ID: 1493303 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-07
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Sudden death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210731982

Write-up: SUDDEN DEATH; FAINT; INTENSE HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the day of vaccination during night, the patient had intense headache. By the early morning of 08-JUL-2021, the patient fainted and had sudden death. On 08-JUL-2021, the patient died from unknown cause of death. The reporter stated that, the patient received a single dose vaccine, reason why reporter assumed it was the Janssen covid-19 vaccine. An autopsy was performed on an unspecified date reported sudden death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had sudden death on 08-JUL-2021, and the outcome of intense headache and faint was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210731982- Covid-19 vaccine ad26.cov2.s- Sudden death, Faint. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1495601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Body mass index, Haemoglobin, Ischaemic stroke, Magnetic resonance imaging head, Platelet count, White blood cell count
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LERCANIDIPINE HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal wall wound; Appendectomy; Body mass index high; Hypertension arterial; Inguinal hernia; Lithiasis; Surgery (Surgery for lithiasis under maxillary G in June 2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: creatinine; Result Unstructured Data: Test Result:77 umol/l; Test Name: BMI; Result Unstructured Data: Test Result:31; Test Date: 20210708; Test Name: hemoglobin; Result Unstructured Data: Test Result:153 g/l; Test Date: 20210707; Test Name: brain mri; Result Unstructured Data: Test Result:total sylvian left ischemic stroke; Comments: total sylvian left ischemic stroke, with extensive lesions in DWI, ASPECTS 1/10, not visible in FLAIR; Test Date: 20210708; Test Name: platelets; Result Unstructured Data: Test Result:617; Comments: Giga per liter; Test Date: 20210708; Test Name: WBC; Result Unstructured Data: Test Result:25.15; Comments: giga per liter
CDC Split Type: FRPFIZER INC2021896194

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number FR-AFSSAPS-LY20217710. A 55-year-old male patient received second dose of bnt162b2 (COMIRNATY), dose 2 intramuscular on 05Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date, BMI 31, lithiasis from an unknown date, surgery from Jun2021 to an unknown date (Surgery for lithiasis under maxillary G in Jun2021), abdominal wall wound from an unknown date(Abdominal wound by knife), appendicectomy from an unknown date , inguinal hernia from an unknown date and all unknown if ongoing. Concomitant medication included lercanidipine hcl (LERCANIDIPINE HCL) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY), for covid-19 immunization. The patient experienced ischemic stroke on 07Jul2021. The patient underwent lab tests and procedures which included blood creatinine: 77 umol/l on 08Jul2021 , body mass index: 31, haemoglobin: 153 g/l on 08Jul2021, magnetic resonance imaging head: total sylvian left ischemic stroke on 07Jul2021 total sylvian left ischemic stroke, with extensive lesions in DWI, ASPECTS 1/10, not visible in FLAIR , platelet count: 617 on 08Jul2021 Giga per liter , white blood cell count: 25.15 on 08Jul2021 giga per liter. The patient died on Jul2021. An autopsy was not performed. The clinical course was reported as follows: 05Jul2021 vaccination with a second dose of Comirnaty vaccine lot unknown. 07Jul2021 around 17:40 , right hemiplegia and aphasia, with description of initial loss of consciousness. Management in the outpatient department. Brain MRI at 19:20: total sylvian left ischemic stroke, with extensive lesions in DWI(?), ASPECTS 1/10, not visible in FLAIR. With occlusion at the GIC(?) termination. Transfer to neurology for thrombectomy. 08Jul2021 hemorrhagic transformation of the stroke and major edema with subfalcoral and temporal involvement, with brainstem compression. Given the severity of the lesions, no indication for craniectomy, referral for comfort care. Additional examinations: 08Jul2021 WBC 25.15G/L, Hb 153g/L, platelets 617 G/L, creatinine 77 umol/L. Lot number: Unknown. Event Outcome: Fatal. No follow-up attempts possible. Lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1496682 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021862752

Write-up: Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118376. An 80-year and 9-month-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration (age at vaccination reported as 80-year-old) on 03Jul2021 10:50 (Lot Number: EY5422; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jul2021 (4 days after the vaccination), the patient experienced pyrexia. It was not reported if an autopsy was performed. The course of the events was as follows: The reporting physician was informed by the patient''s family that the patient developed fever and after that, he died. The patient underwent lab tests and procedures which included body temperature before vaccination: 36.4 centigrade on 03Jul2021. The patient died on 08Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pyrexia


VAERS ID: 1464551 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None reported
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Discovered dead in residence three days after vaccination. Last seen alive on day of vaccination


VAERS ID: 1484677 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-21
Onset:2021-07-06
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Carditis, Death, Electrocardiogram abnormal, Inflammation
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hair, Skin, nail vitamin B6 Calcium
Current Illness:
Preexisting Conditions: LUpus
Allergies: NONE
Diagnostic Lab Data: EKG
CDC Split Type:

Write-up: Daughter stated that patient passed on 07/06, a few weeks after getting her 1st vaccine. Daughter stated that she noticed that her mother had stomach pains the day before and the day of passing. Daughter stated tat Mother had EKG test and heart inflammation was found. Patient passed due to heart inflammation.


VAERS ID: 1484908 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-22
Onset:2021-07-06
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Death, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death J18.9 - Pneumonia N17.9 - Acute renal injury


VAERS ID: 1484925 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-26
Onset:2021-07-06
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Death, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung - Acute kidney failure, unspecified


VAERS ID: 1484966 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-12
Onset:2021-07-06
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7534 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Blood osmolarity decreased, Death, Hyponatraemia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia


VAERS ID: 1488328 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-06
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (active smoking); Comments: Tabac
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021882818

Write-up: Death sudden; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20212563. A 42-year-old male patient received BNT162B2 (COMIRNATY), first dose, intramuscularly, administered in arm left on 28May2021 (Batch/Lot Number: FA8016) at single dose for covid-19 immunisation. Medical history included smoker (active smoking). The patient''s concomitant medications were not reported. The patient experienced death sudden on 06Jul2021. Death of the patient was noted on 06Jul2021. The patient had not given any news for 24 hours. There was no family there. The patient''s only antecedent was active smoking, no toxicants were found at home, no notion of alcohol intake reported. The patient is found on the floor in his toilet. As the death did not seem to be atorture, there was no forensic autopsy requested. The declarer mentioned a sudden death of probable cardiovascular origin, in a context of vaccination against Covid-19, with Comirnaty. The patient died on 06Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Death sudden


VAERS ID: 1492470 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bedridden; Cerebellar infarction; Debility (senile); Disuse syndrome; Gavage
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021849224

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21117945. A 98-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EY5423; Expiration Date: 31Aug2021), via an unspecified route of administration on 05Jul2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included cerebellar infarction on 13Mar2021, atrial fibrillation on 13Mar2021, tube feeding from 2021 to an unknown date, bedridden from 2021 to an unknown date, general debilitation (senile) from 2021 to an unknown date, and disuse syndrome from 2021 to an unknown date. Family history and concomitant medications were not reported. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 14Jun2021 for COVID-19 immunisation. On 06Jul2021 at 06:30, the patient experienced respiratory arrest, which was serious for death. The clinical course was as follows: on 13Mar2021, the patient experienced an onset (cerebellar infarction) and was admitted to the local hospital on the same day. Atrial fibrillation was noted. Because oral ingestion was impossible, tube feeding was performed. On 19May2021, the patient was transferred to the reporting hospital for his recuperation. The patient was bedridden and could hardly express his will for tube feeding. On 05Jul2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 via an unspecified route of administration as a single dose for COVID-19 immunisation. Regarding his condition, he was being debilitated. On 06Jul2021at 06:30 (16 hours after the vaccination), the patient experienced respiratory arrest. At 07:57, his death was confirmed. The patient underwent lab tests and procedures which included body temperature: 37 degrees Centigrade on 05Jul2021 before vaccination. The clinical outcome of the event was fatal. The patient died on 06Jul2021 due to respiratory arrest. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause(s) of the event such as any other diseases was cerebellar infarction. The reporting physician commented as follows: the patient had general debilitation and was senile. He had disuse syndrome. About 16 hours had passed after the injection given this time. The physician considered unassesable or unrelated and reported this case.; Sender''s Comments: Based on the available information, the event respiratory arrest was unrelated to the suspect product BNT162B2 (COMIRNATY). the underlying medical history of cerebellar infarction may have played an important contributory role. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1493492 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202100920603

Write-up: Death; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority BE-FAMHP-DHH-N2021-101750 received by the Belgian authorities. A 61-year-old female patient received bnt162b2 (COMIRNATY) second dose at the age of 61-year-old on 06Jul2021 (lot: FE2625) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Death on 06Jul2021. No side effect per se. Death on the same day as second vaccination. It was unknown if Autopsy Done. The outcome of the event was Fatal. Reporters comments: Treatment - Evolution of the ADR - ADR description - No side effect per se. Death on the same day as second vaccination. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Evolution of the ADR - ADR description - No side effect per se. Death on the same day as second vaccination.; Reported Cause(s) of Death: death


VAERS ID: 1496614 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Pneumonia, X-ray
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm; Colon cancer; Gavage; Myocardial infarction; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210706; Test Name: X-ray test; Result Unstructured Data: Test Result:revealed pneumonia findings
CDC Split Type: JPPFIZER INC2021857519

Write-up: Pneumonia; This is a spontaneous report from a contactable physician via Regulatory Agency. The patient was an elderly male. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no relevant past drug history. There were no known allergies. Other medical history included pneumonia aspiration, myocardial infarction, aortic aneurysm, colon cancer, and tube feeding via gastric fistula. The patient had experienced recurrent pneumonia aspiration and had been in the hospital for tube feeding via gastric fistula. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jul2021 at unknown time, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscularly for COVID-19 immunization. After the vaccination, the patient experienced no abnormality. On 06Jun2021 (1 day after the vaccination), the patient experienced pneumonia. On 06Jul2021 around 10:00, the patient had decreased oxygen saturation and started to receive oxygen. X-ray test revealed pneumonia findings. Tube feeding was stopped, and the patient received transfusion and antibiotics. On 08Jul2021 (3 days after the vaccination), he died. The death cause was pneumonia. No autopsy was performed. Treatment given for the adverse event included antibiotics, fluid replacement, and steroids. The reporting physician assessed the event as serious (death). The causality of the event was not reported.; Sender''s Comments: Based on the information currently available,The casual association between the reported event "pneumonia" and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1496619 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021857863

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 71-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), at the age of 71-year-old, via an unspecified route of administration on 05Jul2021 (the day of vaccination) (Lot number unknown, Expiration date unknown) as single dose for COVID-19 immunization. The patient had no allergies and no underlying diseases. Concomitant medications were not reported. On 06Jul2021 (one day after the vaccination), the patient died. The cause of death was not reported. The course of the event was as follows: On 05Jul2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. The patient was followed up for approximately 15 minutes at the clinic. No abnormalities were observed, thus, he went home. On 06Jul2021 (one day after vaccination), the patient died at his home. Since this report was obtained from the police, the cause of death and others were unknown. The causality between the event and BNT162b2 was not provided. It was not reported if Autopsy Done. The outcome of the event was Fatal.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The contribution of patient''s age cannot be completely ruled out in the occurrence of the event death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1458145 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-06-30
Onset:2021-07-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac valve rupture, Chest pain, Cough, Death, Headache, Pain, Pyrexia, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole dr 20 mg capsule Lisinopril 10 mg tablet
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: N/a
Diagnostic Lab Data: Aortic valve rupture 7/8/21
CDC Split Type:

Write-up: Fever, coughing, body ache, head ache, congestion, chest pain, death


VAERS ID: 1467239 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: C-reactive protein, Death, Deep vein thrombosis, Fibrin D dimer, Full blood count, Metabolic function test, Pulmonary embolism, Renal function test, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Various asthma and anxiety medications
Current Illness: No
Preexisting Conditions: Emphysema, anxiety
Allergies: No
Diagnostic Lab Data: FBC, U&E, CMP, CRP, D-Dimer, Covid-19 PCR: 10/07/2021
CDC Split Type:

Write-up: Deep vein thrombosis and pulmonary embolisms 3 days after vaccine, and death 11 days after vaccine.


VAERS ID: 1488962 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial pneumonia; Large intestine carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021842456

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117735. The patient was an 81-year and 2-month-old male. Body temperature before vaccination was 36.3 degrees centigrade. The family history was not provided. The patient had medical histories of large intestine carcinoma and interstitial pneumonia. On 04Jun2021 at 10:40 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EW0201, Expiration date: 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Jul2021 at 03:00 (16 hours and 20 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 05Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 04Jul2021 (the day of vaccination), at 10:40, the patient received the first dose of BNT162b2 vaccination. After lunch, the patient went home. He lived alone. On 05Jul2021, at 03:00 (16 hours and 20 minutes after vaccination), when the patient''s son visited the patient in the morning, he was found to have cardio-respiratory arrest on the bed. The patient was emergently transferred. The patient did not respond to resuscitation, and he was confirmed to die at 07:56 (21 hours and 16 minutes after vaccination). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was interstitial pneumonia. The reporting physician commented as follows: Since the change was after the resuscitation, it was difficult to be judged on the autopsy imaging (AI). However, the patient seemed to also have lung oedema. Since there was an image of interstitial pneumonia which was medical history, the degree of the new change was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1488992 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUGLUCON; GLACTIV; AMLODINE [AMLODIPINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021843290

Write-up: Suicide; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was a 78-year-old male. The patient had medical histories of diabetes mellitus and hypertension. The concomitant medications included oral glibenclamide (EUGLUCON Tablet) at 1.25 mg daily, oral sitagliptin phosphate hydrate (GLACTIV Tablet) at 50 mg daily, and oral amlodipine besilate (AMLODIN Tablet) at 5 mg daily. Historical vaccine included first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On 03Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On 05Jul2021 (2 days after the vaccination), the patient experienced suicide. On 05Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 05Jul2021 (2 days after vaccination), the patient experienced suicide. The causality between the event and BNT162b2 vaccination was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Suicide


VAERS ID: 1489034 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Cardio-respiratory arrest, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021846718

Write-up: vaccination site pain; suspected acute cardiac death; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117855. The patient was a 92-year and 6-month-old male. Body temperature before vaccination was not performed. It was unknown if the patient had medical history or if he was receiving concomitant medications. On 02Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 23Jun2021 (the day of vaccination) (at the age of 92 years old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) an unspecified route of administration as dose 2, single for COVID-19 immunization. On 05Jul2021 at around 06:00 am (12 days after the vaccination) also reported as 08:40 am, the patient experienced cardio-respiratory arrest and died. The course of the events was as follows: On 02Jun2021 and 23Jun2021, the patient received BNT162b2 at the same hospital. After the vaccination on an unspecified date, there were no marked problems other than vaccination site pain. On 05Jul2021 at around 08:40 in the morning, the patient was found in a state of cardio-respiratory arrest by his family. Although they called 119, it was deemed as social death, and so he was not transferred to a hospital. Postmortem examination was performed as abnormal death. Based on the postmortem examination, acute cardiac death was suspected. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event such as any other diseases. The reporting physician commented as follows: The reporter was in charge of the postmortem examination. The reporter had not met the patient while he was alive. The vaccination he received was BNT162b2, and any further information beyond this was uncertain.; Reported Cause(s) of Death: Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: suspected acute cardiac death


VAERS ID: 1489047 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Death, Imaging procedure
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Imaging; Result Unstructured Data: Test Result:no findings including cerebral haemorrhage
CDC Split Type: JPPFIZER INC2021846759

Write-up: Cardiac death; cause of death was unknown; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 68-year-old male. Medical history included hypertension and type 2 diabetes mellitus. On 04Jul2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) intramuscular as a DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient''s concomitant medications were not reported. On 05Jul2021 (1 day after the vaccination), the patient experienced cardiac death. The course of the event was as follows: On 05Jul2021, the patient was emergently transferred to the reporting hospital and death was confirmed. Imaging on Jul2021 revealed no findings including cerebral haemorrhage and it was assessed as cardiac death. Information was received from family member that on 04Jul2021, the patient received Pfizer''s vaccine at another city. The outcome of the event was fatal. Patient died on 05Jul2021. Cause of death was unknown (as reported). Causality was unknown but could not be denied. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unknown but could not be denied. Reporter''s Comment: Cause of death was unknown (as reported). Causality was unknown but could not be denied. Information on lot/batch number has been requested.; Reporter''s Comments: Cause of death was unknown (as reported). Causality was unknown but could not be denied.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cause of death was unknown; Cardiac death


VAERS ID: 1489089 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021849244

Write-up: Unknown cause of death; slightly tired; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is i21102281. The patient was a 94-year-old male. Height and weight: unknown. Pregnancy: no. Adverse reaction history: unknown. Primary disease/complication: prostate cancer. Special notes: alcohol/smoking/allergy, all unknown. On 05Jul2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) (at the age of 94-year-old) at 0.3 mL intramuscularly as a single dose for COVID-19 immunisation. On 05Jul2021 at unknown time (after an unknown time gap from the vaccination), the patient experienced death. The outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: On 05Jul2021 (the day of vaccination), a 15-minute observation of health condition was performed. The patient had no symptoms of immediate allergic anaphylaxis and went home. He told his family that he was slightly tired. The patient felt better in the afternoon after having a sleep, and a wait-and-see approach was taken. Thereafter, the family found the patient dead early in the morning. Details such as causality with the vaccine were unknown. Procedure/diagnosis except those mentioned above that has an effect on the onset of the adverse reaction or others: no. Re-administration: no. The outcome of the event slightly tired was recovered on 05Jul2021. The reporting physician classified the event as serious. The causality of the event was not reported. The reporting physician commented as follows: There was a lack of information on drug therapy given after surgery of prostate cancer. No serious problem was noted in particular at the time of vaccination, and during the 15-minute observation of health condition, the patient was sitting on the chair and later walked back home by himself (with assistance). It was completely unclear whether the event was caused by the underlying disease, other factors, or the vaccine. The causal relationship was totally unclear as well.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1489228 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-05
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood glucose, Blood lactic acid, Blood pH, Blood potassium, Blood sodium, Haemoglobin, Myocardial infarction, PCO2, PO2
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cannabis use (Medical history: none, except for cannabis use that, according to the anamnesis, has not been used for six months.)
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Sodium; Result Unstructured Data: 137 (unit unspecified); Test Date: 20210705; Test Name: PCO2; Result Unstructured Data: 125 (unit unspecified); Test Date: 20210705; Test Name: Lactate; Result Unstructured Data: 14,6 (unit unspecified); Test Date: 20210705; Test Name: Potassium; Result Unstructured Data: 4,3 ( (unit unspecified); Test Date: 20210705; Test Name: Blood pH; Result Unstructured Data: <6,8 (unit unspecified); Test Date: 20210705; Test Name: PO2; Result Unstructured Data: 17 (unit unspecified); Test Date: 20210705; Test Name: Hemoglobin; Result Unstructured Data: 9,1 (unit unspecified); Test Date: 20210705; Test Name: Glucose; Result Unstructured Data: 20.1 (unit unspecified); Test Name: Autopsy; Result Unstructured Data: first (provisional) findings autopsy: thrombus...
CDC Split Type: NLJNJFOC20210731464

Write-up: MYOCARDIAL INFARCTION WITH OCCLUDED LAD; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00614588] concerned a 24 year old male patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included cannabis use according to the anamnesis, had not used for six months.. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: unknown) 1 dosage forms, 1 total administered on 27-JUN-2021 for covid-19 immunisation (Drug start period- 7 days). No concomitant medications were reported. On 05-JUL-2021, the patient experienced myocardial infarction with occluded LAD (left anterior descending artery) and also died from myocardial infarction. An autopsy was performed on an unspecified date. Laboratory data included: Blood pH result was <6, 8 (unit unspecified), Glucose was 20.1 (unit unspecified), Hemoglobin was 9, 1 (unit unspecified), Lactate was 14, 6 (unit unspecified), PCO2 (partial pressure of carbon dioxide) was 125 (unit unspecified), PO2 (partial pressure of oxygen) was 17 (unit unspecified), Potassium was 4, 3 ( (unit unspecified), and Sodium was137 (unit unspecified). Laboratory data (dates unspecified) included: Autopsy (NR: not provided) first (provisional) findings autopsy: thrombus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210731464-covid-19 vaccine ad26.cov2.s-Myocardial infarction with occluded LAD. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MYOCARDIAL INFARCTION; Autopsy-determined Cause(s) of Death: MYOCARDIAL INFARCTION


VAERS ID: 1492439 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021847686

Write-up: Death; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is v21117900. A 61-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FC5947; Expiration Date: 30Sep2021), via an unspecified route of administration, on 01Jul2021 (reported as: in the afternoon) (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient experienced death on 05Jul2021 (4 days after the vaccination), which was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.0 degrees centigrade on 01Jul2021. On 01Jul2021 (the day of vaccination), the patient received the first vaccination. On 05Jul2021 (4 days after the vaccination), the patient was found dead at the company''s warehouse. The details were unknown. The patient died on 05Jul2021. The cause of death was reported as unknown cause of death. It was not reported if an autopsy was performed. The reporting pharmacist assessed the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1492514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood creatine phosphokinase, Blood creatinine, Blood glucose, Blood potassium, Body temperature, C-reactive protein, Cardio-respiratory arrest, Imaging procedure, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: CPK; Result Unstructured Data: Test Result:2453; Test Date: 20210706; Test Name: CRE; Result Unstructured Data: Test Result:1.75; Test Date: 20210706; Test Name: Glucose; Result Unstructured Data: Test Result:26; Test Date: 20210706; Test Name: K; Result Unstructured Data: Test Result:7.1; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:41 Centigrade; Test Date: 20210706; Test Name: CRP; Result Unstructured Data: Test Result:0.05; Test Date: 202107; Test Name: Ai-CT; Result Unstructured Data: Test Result:pulmonary oedema-like finding
CDC Split Type: JPPFIZER INC2021855569

Write-up: Cardiopulmonary arrest (CPA); Consciousness disturbed; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118189. A 68-year-old female received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose on 03Jul2021 at 15:02 (the day of vaccination), for COVID-19 immunization. Medical history and concomitant medication were not reported.Body temperature before vaccination was 36.5 degrees centigrade. On 05Jul2021 (2 days after the vaccination), the patient experienced pyrexia. On 06Jul2021 (3 days after the vaccination), the patient experienced cardiopulmonary arrest (CPA) and consciousness disturbed.On 06Jul2021 (3 days after the vaccination), Outcome of Cardio-respiratory arrest was fatal, others was unknown.The course of the events was as follows:On 03Jul2021, the patient received the first dose of the vaccine. On 05Jul2021, the patient developed pyrexia. On 06Jul2021, family member noticed that the patient had consciousness disturbed and pyrexia of 41 degrees centigrade, for which ambulance was requested. When emergency medical service arrived, the patient was in CPA and cardiopulmonary resuscitation was performed until the patient arrived at the hospital. However, the patient died. Autopsy imaging (AI) CT revealed pulmonary oedema-like finding. During resuscitation, blood test showed creatine phosphokinase (CPK) 2453, creatinine (CRE) 1.75, Potassium (K) 7.1, C-reactive protein (CRP) 0.05, and glucose 26. Pathological autopsy was conducted; however, cause of death could not be identified macroscopically.Therapeutic measures were taken as a result of Cardio-respiratory arrest.The reporting physician classified the events as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases could not be judged.The cause of death was unknown. The reporting physician commented as follows:At the time of this report, there was no clear evidence for causality between the event and the vaccine. Result of pathological autopsy was awaited. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1496616 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Hypertension; Osteoporosis; Tuberculosis
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021857697

Write-up: Haematemesis; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21118715. An 85-year and 5-month-old female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 02Jul2021 at 14:40 (Lot Number: FA5765; Expiration Date: 30Sep2021) (at the age of 85-year-old) as single dose for COVID-19 immunisation. Medical history included tuberculosis, chronic obstructive pulmonary disease, hypertension and osteoporosis all from an unknown date and unknown if ongoing. The family history was not provided. The patient''s concomitant medications were not reported. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot Number and Expiration date were not reported). Body temperature before vaccination was 36.9 degrees centigrade. On 02Jul2021 at 14:40 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY). No abnormalities were observed on the medical interview. Since no change was observed in the physical condition while the patient was waiting for 15 minutes after the vaccination, she went home. On 04Jul2021, at around 15:00 (2 days after the vaccination), it was reported that the patient talked with her neighborhood with energy. On 05Jul2021 (3 days after the vaccination), the patient experienced haematemesis. In the morning, the patient did not respond to the contact from the family, and the family visited the patient. The patient died with haematemesis on the bed. It was not reported whether an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were as follows: The patient had tuberculosis when she was young. Recently, the patient was being treated with an inhalant and other medications for chronic obstructive pulmonary disease. The patient was being treated with administration of drugs for hypertension and osteoporosis.; Reported Cause(s) of Death: Haematemesis


VAERS ID: 1496634 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Cerebellar infarction, Computerised tomogram head, Eye movement disorder, Feeding disorder, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Von Recklinghausen''s disease (of nerve)
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210705; Test Name: Head CT; Result Unstructured Data: Test Result:bilateral cerebellar infarction
CDC Split Type: JPPFIZER INC2021858625

Write-up: Cerebellar infarction; Consciousness disturbed; Unable to eat; Ocular deviation; muscle weakness right upper limb; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118246. A 55-year and 11-month-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EY3860; Expiration Date: 31Aug2021), via an unspecified route of administration on 29Jun2021 at 10:00 (at 55 years) as single dose for covid-19 immunisation. Medical history included Von Recklinghausen''s disease (not ongoing, as reported). Family history and concomitant drugs were not provided. Body temperature before vaccination on 29Jun2021 was 36.1 degrees Centigrade.On 05Jul2021 (6 days after the vaccination, as reported), the patient experienced cerebellar infarction. The course of the events was also described as follows: On 05Jul2021 in the morning, as there was something wrong with the patient''s condition and she could not consume her lunch (feeding disorder), she visited the reporter''s hospital. Consciousness disturbed, ocular deviation (conjugation to left) and muscle weakness right upper limb were noted. Head CT scan showed bilateral cerebellar infarction. On the same day, the patient was admitted to a different hospital.Treatment was given.On 06Jul2021 (7 days after the vaccination), the patient died. It was not reported if an autopsy was performed. Event cerebellar infarction was fatal; outcome of the other events was unknown. The reporting physician classified the event as serious (hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. Atherothrombosis was considered as a possible cause of the event. The physician commented that the patient had medical history of Von Recklinghausen''s disease.; Reported Cause(s) of Death: Atherothrombosis; Cerebellar infarction


VAERS ID: 1496680 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: IMIDAPRIL HYDROCHLORIDE; DIPYRIDAMOLE; SITAGLIPTIN PHOSPHATE MONOHYDRATE; IMIDAFENACIN; FEXOFENADINE HYDROCHLORIDE; ROSUVASTATIN CALCIUM; BETAHISTINE MESILATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Frailty; Geromarasmus; Hypertension; Lipid metabolism disorder; Oral intake reduced; Overactive bladder; Parenteral nutrition; Rhinitis allergic; Type 2 diabetes mellitus; Vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:No increased body temperature was observed; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: in morning
CDC Split Type: JPPFIZER INC2021862719

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21118723. An 87-year-old (as reported 87-year and 10-month-old) female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration at the age of 87-year-old (as reported 87-year and 10-month-old) on 03Jul2021 14:05 (Lot Number: EW0201; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. Medical history included hypertension, angina pectoris, type 2 diabetes mellitus, lipid metabolism disorder, overactive bladder, rhinitis allergic, and inner ear vertigo, Frailty progressed, poor oral intake, parenteral nutrition, geromarasmus. Body temperature before vaccination was 36.6 degrees centigrade on 03Jul2021. The vaccination and disease within one month: the patient did not receive vaccination. Frailty progressed, and the patient had poor oral intake, for which a parenteral nutrition was prescribed. Concomitant medications included imidapril hydrochloride; dipyridamole; sitagliptin phosphate monohydrate; imidafenacin; fexofenadine hydrochloride; rosuvastatin calcium; betahistine mesylate, all taken for an unspecified indication from an unspecified start date and ongoing; other concomitant medication also included parenteral nutrition 400 mL 2x. On 05Jul2021 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. On 05Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 05Jun2021 (2 days after vaccination), when the patient''s daughter cared for the patient in the morning, the body temperature was 37.1 degrees Celsius, and she had slight hot feeling around the neck by touch. The daughter made the patient had a little fluid, and she took over to the patient''s son. In the afternoon, the son made the patient had a little fluid and lay her down. No increased body temperature was observed. In the evening, the son saw how the patient was doing, and he noticed that the patient was not breathing. An ambulance was called, and the patient was transferred to the accident and emergency department in the university hospital, where the patient died. The patient was diagnosed with geromarasmus by the attending physician at the emergency department (the physician seemed not to explain that the patient received the BNT162b2 vaccination on 03Jul2021). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The frailty progressed since 1 to 2 weeks before, and the amount of meal intake and fluid intake significantly decreased. The reporting physician commented as follows: Since the patient was an elderly of 87-year-old, and she had various underlying diseases, and the frailty progressed, the attending physician considered that the patient died due to geromarasmus. It was considered unlikely that the first dose of BNT162b2 vaccination was related to the death. The family understood the course until the death. The family also did not consider that the death was affected by the BNT162b2 vaccination. However, since the patient died 2 days after the BNT162b2 vaccination, this case was reported with unknown causality. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 03Jul2021 (Before vaccination), body temperature: 37.1 centigrade on 05Jul2021 (in morning), body temperature: no increased body temperature was observed on 05Jul2021. The patient died on 05Jul2021. It was not reported if an autopsy was performed. The outcome of event was fatal.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1446849 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-02
Onset:2021-07-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 AR / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Holcomb''s disease; hypertrophic cardiomyopathy
Allergies: None
Diagnostic Lab Data: none
CDC Split Type:

Write-up: death


VAERS ID: 1454364 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-02-03
Onset:2021-07-04
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / 1 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9261 / 2 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Confusional state, Cough, Death, Dyspnoea, Fatigue, SARS-CoV-2 RNA increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: Dementia, hypertension, Parkinson''s
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: ~5 months following vaccination, COVID-19 infection: Abnormal CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive; Patient died as result of illness 4 days after admittance to hospital from nursing home.


VAERS ID: 1454651 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2020-12-21
Onset:2021-07-04
   Days after vaccination:195
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8982 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: A-fib, CAD, Chronic anticoagulation, Chronic kidney disease, CHF, COPD, dependence on nocturnal oxygen therapy, dyspnea, HTN, Type 2 diabetes, heart disease
Allergies: Adhesive tape, iodine, Isovue-370, lisinopril, MSG, and shellfish
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was admitted to the hospital on 7/4 and tested positive for covid. Pt died 7/6


VAERS ID: 1487364 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-04-01
Onset:2021-07-04
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Neurodegenerative disorder, Paralysis, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: potassium, levothyroxine, tizanidine, gabapentin, diflofenac
Current Illness: polyneuropathy, arthritis, chronic back pain, hyperesthesia, history of falls Patient did not go for follow-up
Preexisting Conditions: as above
Allergies: NKDA
Diagnostic Lab Data: none went on hospice
CDC Split Type:

Write-up: patient went on hospice 7/16/21 and expired 7/17/21 developed sudden neuro degenerative disease unspecified with paralysis of lower extremities first then arms, neck and complained of shortness of breath, swelling left and then progressive swelling


VAERS ID: 1485731 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Arrhythmia, Body temperature, Cardio-respiratory arrest, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRAZAXA
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Asphyxia; Aspiration; Respiratory arrest
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210704; Test Name: Vital signs; Result Unstructured Data: Test Result:no abnormal vital signs; Comments: at 15:35
CDC Split Type: JPPFIZER INC2021832047

Write-up: lethal arrhythmia; Cardio-respiratory arrest (anaphylaxis); Cardio-respiratory arrest (anaphylaxis); This is a spontaneous report from a contactable physician via Medical Information and from the Agency Regulatory Authority. Regulatory authority report number is v21117591. The patient was an 87-year and 6-month-old female. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. Medical history included prior aspiration, historical asphyxia due to aspiration, prior respiratory arrest of unknown cause, and admission to a group home for past medical history. Concomitant medications included dabigatran etexilate mesilate (PRAZAXA). On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 04Jul2021 at 13:20 (the day of vaccination, at 87-year and 6-month-old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 04Jul2021 at 15:50 (2 hours and 30 minutes after the vaccination), the patient experienced cardio-respiratory arrest (anaphylaxis). On 04Jul2021 at 18:04 (4 hours and 44 minutes after the vaccination), the outcome of the events was fatal. Autopsy was done. The course of the events was as follows: The patient had background as mentioned above and was on follow-up at the reporting hospital as outpatient after admission to a group home. On 04Jul2021, the patient finished all her breakfast and lunch and had no pyrexia. Therefore, on 13:20, she received the BNT162b2 vaccination. Thereafter, she also ate all the snacks, and at 15:35, there were no abnormal vital signs. However, at 15:50 (2 hours and 30 minutes after the vaccination), the facility staff noticed her loss of consciousness and called an ambulance. Because of cardio-respiratory arrest, an intravenous route was secured, and cardiopulmonary resuscitation (CPR) with intravenous injection of adrenaline was performed. During these interventions, the patient was transported to Hospital with the reporter on the vehicle, but resuscitation was unsuccessful, and at 18:04 (4 hours and 44 minutes after the vaccination), she died. Although the reporting criteria was anaphylaxis because of the onset within 4 hours after the vaccination, the patient also had a past history of aspiration and respiratory arrest of unknown cause; the causal relationship was unknown according to the autopsy done by the Police, while the death cause recorded on the post-mortem certificate of the hospital was lethal arrhythmia. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases included cardiac failure chronic and Alzheimer''s dementia (historical asphyxia due to aspiration).; Reported Cause(s) of Death: Cardio-respiratory arrest (anaphylaxis); Cardio-respiratory arrest (anaphylaxis); Lethal arrhythmia; Autopsy-determined Cause(s) of Death: Lethal arrhythmia


VAERS ID: 1488960 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Coma scale, Computerised tomogram head, Respiratory arrest, Subarachnoid haemorrhage, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 degree Centigrade; Comments: before vaccination; Test Date: 20210704; Test Name: CS; Result Unstructured Data: Test Result:300; Comments: after vaccination; Test Date: 20210704; Test Name: Head CT; Result Unstructured Data: Test Result:revealed subarachnoid haemorrhage; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021842358

Write-up: Consciousness disturbed; Head CT revealed subarachnoid haemorrhage; respiratory arrest was noted; fainted; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21117728. A 74-year and 08-month-old male the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration on 04Jul2021 at 11:30 (the day of vaccination) (at the age of 74-year and 08-month-old), as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.8 degrees centigrade. Family history, medical history, and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Jul2021 at around 14:00 (2 hours and 30 minutes after the vaccination), the patient fainted at home and was transported by ambulance. The consciousness level was 300 according to the Coma Scale (CS), and respiratory arrest was noted. Head CT revealed subarachnoid haemorrhage. The patient was put on a ventilator and admitted to the reporting hospital. On 05Jul2021 (1 day after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The reporting physician classified the events as serious (death, life-threatening, and hospitalization) and assessed the causality between the events and BNT162B2 as unassessable. It was not reported whether there were other possible causes of the events such as any other diseases.; Reported Cause(s) of Death: respiratory arrest was noted; Consciousness disturbed; subarachnoid haemorrhage


VAERS ID: 1488994 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood test, Cerebellar infarction, Magnetic resonance imaging, Muscle rigidity
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; TERAMURO; TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]; CLOPIDOGREL; EQUMET; MOSAPRIDE [MOSAPRIDE CITRATE]; MITIGLINIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Blood test; Result Unstructured Data: Test Result:extensive cerebellar infarction; Test Date: 20210704; Test Name: MRI; Result Unstructured Data: Test Result:extensive cerebellar infarction
CDC Split Type: JPPFIZER INC2021843304

Write-up: Cerebellar infarction; Limb rigidity; consciousness disturbed; This is a spontaneous report from a contactable pharmacist received from a regulatory authority. Regulatory authority report number is v21117760. The patient was an 85-year and 1-month-old male. Body temperature before vaccination was not reported. Medical history included diabetes mellitus, cerebral infarction and hypertension. Family history was not provided. Concomitant medications orally taken included lansoprazole (LANSOPRAZOLE), amlodipine besilate/telmisartan (TERAMURO), tamsulosin hydrochloride (TAMSULOSIN), clopidogrel (CLOPIDOGREL), metformin hydrochloride/vildagliptin (EQUMET), mosapride citrate (MOSAPRIDE) and mitiglinide (MITIGLINIDE). On an unspecified date, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jul2021 in the morning (the day of vaccination, exact time not provided), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021) an unspecified route of administration as a single dose, DOSE 2, SINGLE for COVID-19 immunization. On 04Jul2021 at 15:00 (the day of vaccination), the patient experienced cerebellar infarction. On 04Jul2021, the patient was hospitalized. On 05Jul2021 (1 day after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 04Jul2021 (the day of vaccination), since the patient''s wife found that the patient groaned and he was in the twilight state, so she called an ambulance. Limb rigidity and consciousness disturbed were noted. Blood test and MRI (magnetic resonance imaging) were performed and the results showed the presence of extensive cerebellar infarction. For the treatment, IV drip of HEPARIN and EDARAVONE was administered. The reporting pharmacist classified the event as serious (life-threatening) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event such as any other diseases. ; Reported Cause(s) of Death: Cerebellar infarction


VAERS ID: 1489055 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODINE [AMLODIPINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021846888

Write-up: Subarachnoid haemorrhage; This is an initial spontaneous report received from a regulatory authority. The regulatory authority report number is v21118284. A contactable physician (anatomy doctor) reported that an 81-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Jun2021 (Batch/Lot number was not reported) at 81-years-old, as dose 2, single for COVID-19 immunization. The patient had medical history of hypertension and findings of arteriosclerosis. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medication included amlodipine besilate (AMLODINE) 2.5 mg taken for hypertension, start and stop date were not reported. On 06Jun2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number not reported, Expiration date not reported) via an unspecified route of administration as the first single dose for COVID-19 immunization. Body temperature before vaccination was not provided. On 27Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as the second single dose for COVID-19 immunization. The patient did not complain of side reactions or physical deconditioning (since there were no vaccination coupons, the details such as the situation at the time of vaccination were unknown). On 04Jul2021, at 14:40 (7 days, 14 hours, and 40 minutes after vaccination) on the receipt was the last time when the patient was conformed to be alive. On 04Jul2021 (7 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 05Jul2021 (8 days after the vaccination), the patient''s child made a call to the patient; however, no response was obtained. Then, the child visited the patient to see how she was doing, and the patient was found dead in the bedroom at around 19:45 on the same day (8 days, 19 hours, and 45 minutes after vaccination). On 06Jul2021, at 10:30 (9 days, 10 hours, and 30 minutes after vaccination), an autopsy was performed in a university. The autopsy showed subarachnoid heamorrhage which was dominant in the right sylvian fissure. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. The reporting physician commented as follows: In addition, the death occurred on day 7 after the vaccination, and thus, the causality between the event and BNT162B2 vaccination was considered unlikely. However, since the causality could not be assessed with only this case, this case was reported. There was no other possible cause of the event such as any other diseases. Information on the batch/lot number has been requested.; Sender''s Comments: Based on information provided, the event subarachnoid haemorrhage is more likely related to underlying disease of hypertension and arteriosclerosis but unrelated to BNT162B2 (COMIRNATY).; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1496695 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Cardio-respiratory arrest, Pneumonia, Pyrexia, Respiratory disorder, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021862870

Write-up: Cardio-respiratory arrest; Bronchial asthma attack; pneumonia could not be excluded; respiratory discomfort; wheezing; low grade fever; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118378. The patient was an 89-year and 5-month-old female. Body temperature before vaccination was 36.4 degrees centigrade. Family history was not reported. Medical history included cardiogenic cerebral infarction. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 30Jun2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021), at the age of 89 years old, via an unspecified route of administration as a single dose for COVID-19 immunisation. On 04Jul2021 (4 days after the vaccination), the patient experienced Bronchial asthma attack, respiratory discomfort, wheezing, and low grade fever. On 05Jul2021 at 03:00 (5 days after the vaccination), the patient experienced cardio-respiratory arrest. On 05Jul2021 (5 days after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: The patient had cardiogenic cerebral infarction. On 30Jun2021 (the day of vaccination), no remarkable side effects were noted also after the second vaccination. However, on 04Jul2021 (4 days after the vaccination), respiratory discomfort and wheezing developed, and a house call was therefore made. Low grade fever was also noted. Although pneumonia could not be excluded as well, bronchodilators and steroids were administered, leading to alleviation. Thereafter, on 05Jul2021 at 03:00 (5 days after the vaccination), the patient was found in a state of cardio-respiratory arrest. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was bronchial asthma attack. The reporting physician commented as follows: While it could not be denied that wheezing was due to aspiration, the effect of the vaccine could not be denied too. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Bronchial asthma attack; Cardio-respiratory arrest


VAERS ID: 1446746 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine Propranolol Zyprexa (olanzepine) Trazadone Vistaril prn
Current Illness: Mental illness: bipolar disorder Possibly showing signs of early onset dementia but this diagnosis was not formally reached during Recent psychiatric in pt hospitalization at. Discharged approx 2 months ago (early May 2021). During hospitalization she experienced weight loss - she went in at 145 lbs, upon discharge she weighted approx 105 lbs.
Preexisting Conditions: Mental illness Otherwise physically healthy except recent weight loss as noted above.
Allergies: No allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: She died


VAERS ID: 1450706 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 256A21A / 1 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden death


VAERS ID: 1460257 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-12
Onset:2021-07-03
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032B21A / 1 - / -

Administered by: Senior Living       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone, Confusional state, Culture urine negative, Death, Fall, Full blood count, Metabolic function test, Oxygen saturation decreased, Respiratory failure, Urine analysis, Vitamin D
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen, atenolol, calcium, cozaar, crestor, lasix, potassium, multivitamin, pepcid, vibramycin
Current Illness: pneumonia, covid illness, hyponatremia, respiratory failure
Preexisting Conditions: gerd, occiptal neuralgia, osteoporosis, htn, diabetes II
Allergies: ciprofloxacin, codeine sulfate, Penicillins, sulfonamide antibiotics
Diagnostic Lab Data: urine w/C&S, CBC, CMP, VITAMIN D, TSH
CDC Split Type:

Write-up: Admitted 6/10/21 w/current covid illness. Partial vaccination noted. 6/17/21 urine culture w/no growth. Progressed to release from Covid unit to general population in recovery status on 6/22/21. Seen/Assessed by NP/MD /IDNP during stay. 6/26/21 urine culture w/no growth. 6/27/21 seen by MD d/t increased falls and confusion. Fall on 6/29/21 w/increased confusion and immediate transport to ER for increased confusion, decreased oxygen saturation and fall w/possible head injury r/t unwitnessed fall and increased confusion. She expired at the hospital 7/3/21 w/respiratory failure.


VAERS ID: 1470347 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-02-09
Onset:2021-07-03
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025A21A / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Death, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATIN,COLCHICINE,PROTONIX,ASA,LISINOPRIL,METOPROLOL,MELOXICAM, PLAVIX,NORVASC,CLONIDINE,POTASSIUM,LASIX,FLONASE,MYSOLINE,AZWLASTINE,VOLTAREN,DUONEB,NORCO,APRECREME
Current Illness:
Preexisting Conditions: CHF, HTN, CHRONIC RESP FAILURE
Allergies: CODEINE
Diagnostic Lab Data: 7/6/2021 SARS COV 2 PCR POSITIVE
CDC Split Type:

Write-up: PATIENT DEVELOPED ACUTE RESPIRATORY AND RENAL FAILURE AND EXPIRED 7/11/2021


VAERS ID: 1484930 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-05
Onset:2021-07-03
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012M20A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Blood osmolarity decreased, Death, Hyponatraemia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death E87.1 - Hypo-osmolality and hyponatremia N17.9 - AKI (acute kidney injury) (CMS/HCC)


VAERS ID: 1484972 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-25
Onset:2021-07-03
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death I61.9 - Intracerebral hemorrhage (CMS/HCC)


VAERS ID: 1476427 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feverish; This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Feverish) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fever. On 11-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Feverish) (seriousness criterion death). The patient died on 07-Jul-2021. The reported cause of death was Feverish. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient died of high fever/brain dead from high fever the vaccine caused. Patient was not enrolled in clinical trial. Treatment medication was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) for events was not applicable. Company Comment This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected.; Sender''s Comments: This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected; Reported Cause(s) of Death: Feverish


VAERS ID: 1488902 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic valve stenosis, Body temperature, Oxygen saturation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; BISOPROLOL; ROZEREM; SPIRONOLACTONE; ASPARA POTASSIUM; CEFAMEZIN ALPHA; ELNEOPA NO.1; POTACOL R; ELNEOPA NO.2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Aortic valve stenosis and insufficiency; Cardiac failure chronic (required hospitalization); Cerebral infarction; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: 22:00; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: 23:00; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: 02:00; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: 08:00; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: 14:00; Test Date: 20210703; Test Name: SpO2; Result Unstructured Data: Test Result:92-93 %; Comments: 23:00
CDC Split Type: JPPFIZER INC2021839907

Write-up: Aortic valve stenosis; This is an initial spontaneous report from a contactable pharmacist received via a regulatory authority. The patient was a non-pregnant 86-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received lansoprazole (manufacture name not reported), bisoprolol (manufacture name not reported), ramelteon (ROZEREM), spironolactone (manufacture name not reported), potassium aspartate (manufacture name not reported), cefazolin sodium (CEFAMEZIN alpha), ELNEOPA NO.1, POTACOL R, and ELNEOPA NO.2 within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cerebral infarction, cardiac failure chronic, hypertension, aortic valve stenosis and aortic valve incompetence. On 03Jul2021 at 15:45 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a hospital. On 03Jul2021 at 22:00 (the day of vaccination), body temperature was 37.1 degrees Centigrade, and shivering appeared. At 23:00, body temperature was 37.9 degrees Centigrade and SpO2 (oxygen saturation percutaneous) was 92-93%. On 04Jul2021 at 02:00 (1 day after the vaccination), body temperature was 39.4 degrees Centigrade. Acetaminophen (ALPINY suppository) was provided as treatment for the event. At 08:00, body temperature was 38.7 degrees Centigrade. At 14:00, body temperature was 37.7 degrees Centigrade. At 15:45, respiratory arrest was found. At 16:17, the patient''s death was confirmed. The cause of death was aortic valve stenosis. An autopsy was not performed. Causality assessment was not provided. Since the vaccination, the patient has not been tested for COVID-19. Follow-up (05Jul2021): New information reported from the same pharmacist via a Pfizer sales representative. New information was as follows: While the patient was being hospitalized for cardiac failure, she received the first dose of the vaccination.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Aortic valve stenosis


VAERS ID: 1488929 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021841742

Write-up: Respiratory arrest; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was a 75-year-old male. The patient family history was not provided. The patient had medical histories of schizophrenia and dementia. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at age of 75 years old as a single dose for COVID-19 immunization. On 03Jul2021 (4 days after the vaccination), the patient experienced respiratory arrest (death). On 03Jul2021 (4 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 03Jul2021 (4 days after vaccination), the patient suddenly died. The cause of death was respiratory arrest. The causality between the event and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event respiratory arrest.This case will be reassessed when additional information, particularly the clinical course before death.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1488938 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Cardio-respiratory arrest, Embolic stroke, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QUETIAPINE; DAYVIGO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardioembolic stroke; Dementia; Paresis cranial nerve
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: pyrexia of 37.8 degrees Centigrade in the evening
CDC Split Type: JPPFIZER INC2021841919

Write-up: Cardioembolic stroke; Cardio-respiratory arrest; Sudden death; Suspected cardiac death; pyrexia of 37.8 degrees Centigrade; This is a spontaneous report from a contactable physician received via a regulatory authority. This report was also received via Pfizer sales representative and another regulatory authority. The regulatory authority report number is v21117885. The patient was a 90-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received quetiapine (QUETIAPINE) 25 mg and lemborexant (DAYVIGO) 2.5 mg (both oral) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cardioembolic stroke, atrial fibrillation, dementia, upper right cerebral paresis on 31May2021 (Since cardioembolic stroke was suspected, he was hospitalized). Body temperature before vaccination was 37.0 degrees Centigrade. On 03Jul2021 at 10:30 (the day of vaccination) (at the age of 90-years-old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscular in the left arm as dose 1, 0.3 ml single for COVID-19 immunization in the ward of the hospital while he was being hospitalized. On 04Jul2021 at 13:00 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest on the bed. After a while, the patient''s death was confirmed (this was also reported as sudden death). The cause of death could not be identified, but given his medical history, cardioembolic stroke was considered as a possible cause. An autopsy was not performed. The event resulted in prolonged hospitalization/death. The outcome of the event was fatal without treatment. The clinical course of the event was reported as follows: On 31May2021, the patient developed upper right cerebral paresis. Since cardioembolic stroke was suspected, he was hospitalized. The treatment of acute-stage cerebral infarction was completed, and his general condition was stable. Therefore, changing hospital was being arranged. On 03Jul2021, the patient received the first dose of BNT162b2. At that night, pyrexia of 37.8 degrees Centigrade was recognized in the evening. Thereafter, no marked change was noted. Until 04Jul2021 at 12:40, no change was seen. At 13:00, the patient was found in cardio-respiratory arrest. CPR (cardiopulmonary resuscitation) was not performed. The outcome of the event pyrexia was unknown; while for the rest of the events was fatal without treatment. The reporting physician assessed the causality between the event and BNT162b2 as unassessable. Cardiac death could be considered as a possible cause. Since the vaccination, the patient has not been tested for COVID-19. Reporter''s comment: Causal relationship between the patient''s death and BNT162b2 was uncertain. Twenty minutes before the patient was found, no problems were noted, and when he was found, he had already been in cardiac arrest. Given those, the possibility of cardiac death was considered.; Reporter''s Comments: Causal relationship between the patient''s death and BNT162b2 was uncertain. Twenty minutes before the patient was found, no problems were noted, and when he was found, he had already been in cardiac arrest. Given those, the possibility of cardiac death was considered.; Reported Cause(s) of Death: Cardioembolic stroke; Cardio-respiratory arrest; Sudden death; cardiac death


VAERS ID: 1489043 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic valve stenosis; Atrial fibrillation paroxysmal; Cardiac failure; Chronic kidney disease; Diabetes mellitus; Hypertension; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021846739

Write-up: Loss of consciousness; Cardio-respiratory arrest; This is an initial spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117736. The patient was a 96-year and 3-month-old male. Body temperature before vaccination and family history were not reported. Medical history included aortic valve stenosis (severe), angina pectoris, diabetes mellitus, hypertension, atrial fibrillation paroxysmal, chronic kidney disease, ischaemic heart disease, and cardiac failure. Concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 02Jul2021 at 13:44 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration as the second single dose for COVID-19 immunisation. On 03Jul2021 at 07:30 (1 day after the vaccination), the patient experienced loss of consciousness and cardio-respiratory arrest. The course of the events was as follows: Since Dec2016, the patient was being followed up at the reporting hospital on outpatient basis. The course of ischaemic heart disease and cardiac failure was relatively favorable. On 03Jul2021 at 03:00 (the day of vaccination), during regular rounds, the patient was sleeping and had no problem. At 07:30, during regular rounds, he was found lying in a state of loss of consciousness and cardio-respiratory arrest. Cardiac massage was provided. The patient was transported to an acute hospital, but it did not help him because he died (death date 03Jul2021). It was unknown whether autopsy was done. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases were aortic valve stenosis and angina pectoris. The reporting physician commented as follows: Cardiac failure due to aortic valve stenosis or anginal attack (acute coronary syndrome) was in the background, and it was very likely that the sudden change was associated with those conditions.; Reported Cause(s) of Death: Loss of consciousness; Cardio-respiratory arrest


VAERS ID: 1492474 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Body temperature, Disease recurrence
SMQs:, Myocardial infarction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Coronary angioplasty
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021849245

Write-up: recurrent acute coronary syndrome; recurrent acute coronary syndrome; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21117970. A 93-year-old female patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: FA5765; Expiration Date: 30Sep2021), via an unspecified route of administration on 02Jul2021 at 08:50 at a single dose for covid-19 immunisation. Medical history included angina pectoris, coronary angioplasty. Family history were not provided. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (Lot Number: EY5420; Expiration date: 31Aug2021) on 11Jun2021 via an unspecified route of administration as a single dose for COVID-19 immunization. After the first dose of vaccination, pyrexia or other symptoms were not present. On 03Jul2021 at 09:00, the patient experienced recurrent acute coronary syndrome, which was serious for death. The clinical course was as follows: on 02Jul2021 at 08:50 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jul2021 at around 09:00 (1 day after the vaccination), the patient died of recurrent acute coronary syndrome. It was not reported if an autopsy was performed. The course of the events was as follows: On 02Jul2021, after the vaccination, the patient was observed until 09:20 and no symptoms were noted. Therefore, she returned home. She was living by herself. On 03Jul2021 at 08:30 (1 day after the vaccination), her family member (who was living separately) visited her and then she complained of poor physical condition, but her consciousness was clear and she could have a conversation normally. Thereafter, the family member cleaned around the house. Thirty minutes later, at around 9:00, the family member found her in a state of cardio-respiratory arrest in the room and asked for an emergency home visit. They were present at her deathbed at home. It was clinically diagnosed that she died of recurrent acute coronary syndrome. The patient underwent lab tests and procedures which included body temperature: 36.1 degrees Centigrade on 02Jul2021 before vaccination. The clinical outcome of the event was fatal. The patient died on 03Jul2021 due to recurrent acute coronary syndrome. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event was reported as follows: The patient had angina pectoris and underwent coronary angioplasty. The reporting physician commented as follows: It was assumed that she died of recurrent acute coronary syndrome. Since 24 hours passed after the vaccination, it was considered that there was no direct relationship with BNT162b2.; Reported Cause(s) of Death: recurrent acute coronary syndrome; recurrent acute coronary syndrome


VAERS ID: 1450176 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039C21A / 1 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Cardioversion, Death, Dyspnoea, Oxygen saturation decreased, Respiratory tract congestion, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ANORO INHALER, CRESTOR, ESOMEPRAZOLE, LEVOTHYROXINE, FOLIC ACID, DILTIAZEM, CARVEDILOL, ASPIRIN, LASIX, MIRTAZAPINE, ALBUTEROL NEBS, FLOVENT INHALER, TYLENOL
Current Illness:
Preexisting Conditions:
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. The following day the patient complained of SOB and the nursing staff found her O2 sat in the 50 so she was brought to the hospital. She was evaluated at the Hospital and discharged back to nursing facility the same day. Patients daughter brought patient back to facility from hospital. On 07/03 patient complained of congestion but "breathing better". On 07/04, patient stayed in bed all day. RN at facility administered tylenol and a soda and right after administration found the patient unresponsive. Nurse started CPR and 911 was called. EMS used defibrillator until the staff alerted EMS that patient was DNR. Patient passed away in room between 3-4pm.


VAERS ID: 1461829 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dead


VAERS ID: 1466464 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-03-01
Onset:2021-07-02
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6202 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Respiration abnormal
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Eliquis, Prinivil, Allopurinol, prilosec, euflexxa
Current Illness:
Preexisting Conditions: history of prostate cancer, A fib, renal insufficiency, hypercholesteremia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 7/3/2021 7:23:41 AM $g phone call from Officer pt deceased. discussed with wife. she heard him make a loud breathing noise at 3am and then could not wake him. had been feeling well with no complaints. planned to run a road race this Sunday. offered support. pls mark chart and then FYI to Dr.


VAERS ID: 1487226 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-02-11
Onset:2021-07-02
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: methadone, tramadol, furosemide, depakote, metformin, klor-con, prilosec, coreg, iron, colestid, lanoxin, cymbalta, namenda, lisinopril, norvasc, xalatan, cosopt, prednisolone, simethicone, aspirin, narcan, tylenol, vit b6, vit d3, melatoni
Current Illness:
Preexisting Conditions:
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away on 07/02/2021


VAERS ID: 1467391 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-02
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021862471

Write-up: concomitant disease progression; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority (RA). Regulatory authority report number is 579532. An 82-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced concomitant disease progression on 02Jul2021. The event was serious, fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: concomitant disease progression


VAERS ID: 1479877 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Disuse syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: PCR; Test Result: Negative ; Comments: nasopharyngeal swab; Test Date: 202107; Test Name: tested for COVID-19; Result Unstructured Data: Test Result:test result was not provided
CDC Split Type: JPPFIZER INC2021830231

Write-up: Pneumonia aspiration; This is a spontaneous report from a contactable physician received through the COVID-19 Adverse Event Self-Reporting Solution. A 77-year-old [non-pregnant] elderly female received the first dose intramuscular of BNT162B2 (COMIRNATY, solution for injection, Lot FA7338 expiry 30Sep2021) as a single dose in the right arm on 01Jul2021 at 14:30 (at 77-years-old) for COVID-19 immunization. Relevant medical history included Disuse syndrome and Cerebral infarction. The patient had no allergies to medications, food, or other products. It was not reported whether the patient received any other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; PCR via nasopharyngeal swab was conducted on 03Jun2021 and was negative. The patient was not pregnant at the time of vaccination. On 01Jul2021 at 14:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the arm right for COVID-19 immunization. On 02Jul2021 at 16:00 (the day following the vaccination), the patient experienced death; cause of death was pneumonia aspiration. The patient was treated with oxygen administration. The event resulted in hospitalization (duration of hospitalization was 30 days as reported) and death. Since the vaccination, the patient has been tested for COVID-19 (test result was not provided). The reporting physician classified the event as serious (death and hospitalization).; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the known safety profile there is not a reasonable possibility that BNT162B2 contributed to the occurrence of the event.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1480207 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-02
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperpyrexia, Illness, Injection site pain, Malaise, Myalgia, Nausea, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Hyperpyrexia; Result Unstructured Data: Fever 40.5 TO 42 Degrees Celsius.
CDC Split Type: NLJNJFOC20210723109

Write-up: PARALYZED; REACTION ON OR AROUND THE INJECTION SITE PAIN; SICK AS A DOG; NAUSEA; JOINT PAIN; COLD CHILLS; FATIGUE; MUSCLE PAIN; FEVER 40.5 TO 42 DEGREES CELSIUS; FEELING UNWELL; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [NL-LRB-00612022] concerned a 48 year old female. The patient''s weight was 75 kilograms, and height was 175 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, at a frequency of 1 total, administered on 02-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-JUL-2021, the patient experienced fever 40.5 to 42 degrees celsius, feeling unwell, headache, joint pain, cold chills, fatigue and muscle pain. On 03-JUL-2021, the patient experienced paralyzed, sick as a dog, reaction on or around the injection site pain and nausea. Laboratory data included: Hyperpyrexia (NR: not provided) Fever 40.5 TO 42 Degrees Celsius. On 03-JUL-2021, the patient died from vaccination complication, fever 40.5 to 42 degrees celsius, paralyzed, feeling unwell, headache, joint pain, cold chills, fatigue, muscle pain, nausea, sick as a dog, and reaction on or around the injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of paralyzed on 03-JUL-2021. This report was serious (Death).; Sender''s Comments: V0 - 20210723109-covid-19 vaccine ad26.cov2.s-Paralyzed, Fever 40.5 to 42 degrees celsius, Feeling unwell, Headache, Joint pain, Cold chills, Fatigue, Muscle pain, Nausea, Sick as a dog, Reaction on or around the injection site pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: VACCINATION COMPLICATION; FEELING UNWELL; HEADACHE; JOINT PAIN; COLD CHILLS; FATIGUE; MUSCLE PAIN; NAUSEA; FEVER 40.5 TO 42 DEGREES CELSIUS; PARALYZED; SICK AS A DOG; REACTION ON OR AROUND THE INJECTION SITE PAIN


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